First-Line Olaparib/Bevacizumab Maintenance Combo Approved in China for HRD+ Advanced Ovarian Cancer

Olaparib (Lynparza) in combination with bevacizumab (Avastin) has been approved in China for the first-line treatment of patients with homologous recombination deficiency (HRD)–positive ovarian, fallopian tube, or primary peritoneal cancer who show complete or partial responses to first-line platinum-based chemotherapy, according to a press release from AstraZeneca.¹

The approval was based on 5-year follow-up from the phase 3 PAOLA-1 trial (NCT02477644), which highlighted a median overall survival (OS) of 75.2 months with olaparib plus bevacizumab maintenance vs 57.3 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer including those with a BRCA mutation (HR 0.62; 95% CI, 0.45-0.85).² Moreover, when BRCA mutations were excluded in the HRD population, the median OS was not reached and 52.0 months, respectively.

The efficacy of this treatment was also supported by updated results from the phase 3 SOLO-1 trial (NCT01844986), which identified clinically meaningful improvement in OS with olaparib monotherapy vs placebo in patients with BRCA-mutated newly-diagnosed advanced ovarian cancer. The 7-year OS analysis indicated that 67% of patients in the experimental arm were alive compared with 47% of those in the control group.

“Historically the 5-year survival rate of newly diagnosed patients with advanced ovarian cancer is 30%-50%. In that context, it is phenomenal to share the long-term [OS] data from both PAOLA-1 and SOLO-1, with 2 of 3 patients still alive in these trials. We continue to believe in Lynparza [Olaparib]’s ability to help biomarker-selected patients with advanced ovarian cancer to achieve better outcomes,” Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said in the press release.

In May 2020, the FDA approved olaparib plus bevacizumab for the treatment of patients with HRD-positive, BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.³

References

1. Lynparza approved in China as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer. News Release. AstraZeneca. September 22, 2022. Accessed September 22, 2022. https://bit.ly/3qVM6SB
2. Lynparza in combination with bevacizumab, and as a monotherapy, demonstrates clinically meaningful survival benefit in 1st-line advanced ovarian cancer across two Phase III trials. News Release. AstraZeneca. September 9, 2022. Accessed September 22, 2022. https://bit.ly/3SooaTj
3. FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers. News release. FDA. May 11, 2020. Accessed September 22, 2022. https://bit.ly/3dBIrpY